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FDA 510(k)

I.T.S. Pelvic Reconstruction System (PRS RX & PRS Phoenix)

K-Number: K210935 · 2022-08-31

ApplicantI.T.S. GmbH
Decision Date2022-08-31
Product CodeHRS
Advisory CommitteeOR
DecisionSubstantially Equivalent

Device Summary

I.T.S. Pelvic Reconstruction System (PRS RX & PRS Phoenix) is a medical device manufactured by I.T.S. GmbH. It received FDA 510(k) clearance on 2022-08-31 under approval number K210935. The device is classified under product code HRS. It was reviewed by the OR advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the I.T.S. Pelvic Reconstruction System (PRS RX & PRS Phoenix)?

I.T.S. Pelvic Reconstruction System (PRS RX & PRS Phoenix) is a medical device that received FDA 510(k) clearance on 2022-08-31. It is manufactured by I.T.S. GmbH. The 510(k) number is K210935.

When was I.T.S. Pelvic Reconstruction System (PRS RX & PRS Phoenix) approved by the FDA?

I.T.S. Pelvic Reconstruction System (PRS RX & PRS Phoenix) received FDA 510(k) clearance on 2022-08-31, under approval number K210935.

What company makes I.T.S. Pelvic Reconstruction System (PRS RX & PRS Phoenix)?

I.T.S. Pelvic Reconstruction System (PRS RX & PRS Phoenix) is manufactured by I.T.S. GmbH.

What is the FDA product code for I.T.S. Pelvic Reconstruction System (PRS RX & PRS Phoenix)?

The FDA product code for I.T.S. Pelvic Reconstruction System (PRS RX & PRS Phoenix) is HRS.

Related Clinical Trials

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Related PubMed Literature

PMID: 42056377 Signal detection of adverse events in medical devices using natural language processing: a case study in pelvic mesh. Scientific reports (2026)

Other Devices by I.T.S. GmbH

K233134I.T.S. INS Proximal Femur Nail K260054I.T.S. PRS Phoenix II

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Official Source

View on FDA Database →

Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.

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